75F40124R00030_CSS_Final.pdf

Document Type: Combined Synopsis/Solicitation

Solicitation Number: 75F40124R00030

Posted Date: February 15, 2024

Response Date: March 11, 2024

NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1000 employees

Contracting Office Address

FDA/OO/OFBA/OAGS/DAP

1201 Main Street Dallas, TX 75202

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 “Streamlined Procedures for Evaluation and Solicitation for Commercial Items”, as supplemented with additional information included on this notice and in conjunction with FAR Part 13.5, Simplified Procedures for Certain Commercial Products and Commercial Services. This announcement constitutes the only solicitation; offers are being requested, and a written solicitation document will not be issued.

The solicitation number is 75F40124R00030. This solicitation is issued as a Request for Quote (RFQ). This solicitation and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2024-02 dated January 22, 2024.

The associated North American Industry Classification System (NAICS) Code for this procurement is 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1000 employees. This combined/synopsis solicitation is full and open competition.

Background: The Food and Drug Administration (FDA)/National Center for Toxicological Research (NCTR)/Division of Neurotoxicology has a requirement for a magnetic resonance imaging (MRI) system with 4 (1-year Post-Warranty Maintenance option periods). The MRI is needed to continue and advance the FDA mission critical research and regulatory science. The MRI is needed to investigate multiple problems related to various types of organ toxicity in vivo, including neurotoxicity and hepatotoxicity. MRI is a powerful tool in all areas of life science, including toxicological sciences, which can study the same animal repeatedly without causing any harm. This allows to optimize the toxicological research, significantly decrease the number of laboratory animals used, and provide the valuable information not accessible by any other means.

The quality of MRI in terms of resolution, noise, and scan times, depends strongly on the magnetic field strength.

Minimum Technical Requirements for a Magnetic Resonance Imaging (MRI) system:

• Shall have a field magnetic strength of 9.0 Tesla or higher.

• Shall have a minimum accessible bore size (with gradient insert) of 100 mm.

• Shall a minimum gradient strength of 600 mT/m.

• Shall include pulse sequences for quantitative relaxometry, diffusion, and spectroscopy methods.

• The system shall be RF-shielded without requirement of external RF shielding.

• Shall include at least second-order shims.

Installation, Training and Warranty Requirements:

• The system and its associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and trouble shooting for the instrument and controlling software. All manuals and documentation on the instrument shall be provided in hard copy and/or electronic format.

• The offeror shall ship, deliver, install the equipment and provide all labor, travel, kits and tools, etc., to install the equipment at the address provided below, to include inside delivery.

• The offeror shall provide training 90 days after installation for the equipment for proper operation of the instrument.

• The offeror shall warrant the entire system for a period of at least one (1) year from acceptance by FDA. The warranty shall include: unlimited telephone/e-mail support for questions regarding operation, onsite visits for diagnosis of problems and repairs inclusive of all parts, labor, and travel expenses at no additional cost to the FDA.

Minimum Performance Requirements for 4 (1-year Post Warranty Maintenance Option Period):

• The Contractor shall provide one (1) scheduled on-site (hardware and software) planned preventive maintenance visit per year.

• The Contractor shall provide unlimited On-Site Corrective Maintenance/Repairs within 3 business days of call for service where problems cannot be resolved remotely after 2 business days.

• The Maintenance and Repair activities shall be performed following the Original Equipment

Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc.

• The Contractor shall include unlimited software and firmware updates during the coverage period(s).

• The Contractor shall include unlimited technical support Monday through Friday (excluding Federal Holidays) 8:00AM – 5:00PM Central Time.

• All maintenance/repair pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc.

Contract Type: Firm Fixed Price

Commercial Item - Firm fixed price. Simplified procurement procedures will be utilized.

An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to furnish required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration.

Contract Line Item

(CLIN)

Description Quantity Unit Unit Price Extended Price

1 Magnetic Resonance Imaging (MRI) system as described in the Minimum Requirements section

1 ea

2 Option Year 1:

Post Warranty Maintenance Option

12 mths

3 Option Year 2:

Post Warranty Maintenance Option

12 mths

4 Option Year 3:

Post Warranty Maintenance Option

12 mths

5 Option Year 4:

Post Warranty Maintenance Option

12 mths

Grand Total Items 1 thru 5

Total Price, Equipment and Options: $_______________________

GSA Contract Number (If applicable): _______________________

*Significant price increases beyond those of expected inflation for Option Year services shall be explained and supported in the offer.

Estimated Delivery Date: 12 months after award

4 (1-year Post-Warranty Maintenance Option periods)

Option Year 1: 03/18/2025 thru 03/17/2026 Option Year 2: 03/18/2026 thru 03/17/2027 Option Year 3: 03/18/2027 thru 03/17/2028 Option Year 4: 03/18/2028 thru 03/17/2029

FOB Destination:

Warranty and preventative maintenance visits shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or WWW.OPM.GOV. Federal holidays are as follows:

New Year’s Day Martin Luther King, Jr.

Washington’s Birthday Memorial Day Juneteenth Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day

Delivery Location:

Food and Drug Administration National Center for Toxicological Research 3900 NCTR Road Building 62, Rooms 106-108 Jefferson, AR 72079

Service Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA Technical Representative and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed.

Clauses and Provisions:

The full text of FAR and HHSAR provisions and clauses may be accessed electronically at http://acquisition.gov/far/index.html or https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html.

CLAUSES

FAR 52.212-4 Contract Terms and Conditions-Commercial Items (Nov 2023)

The following FAR 52.212-4 addenda apply:

The Contractor shall only tender for acceptance of those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services.

Be advised that FDA does not accept documents which contain the use of macros. When submitting documents via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine).

Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

Contractor Performance Evaluation(s) In accordance with FAR Subpart 42.15, FDA will complete annual (interim) and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm. FDA will register the contractor in CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation.

http://acquisition.gov/far/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html http://www.cpars.csd.disa.mil/cparsmain.htm

The Contractor has 14 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 14 days from date the evaluation was issued by the FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions. Evaluations will also be stored for a 3-year period in the https://www.cpars.gov/ system.

Contractors may obtain CPARS training material and register for on-line training at https://www.cpars.gov/lc.htm . There is no fee for registration or use of the CPARS.

Provide the names of two individuals who will be assigned as the CPARS representatives below:

Primary:

Name:

Phone:

E‐mail Address:

Alternate:

Name:

Phone:

E‐mail Address:

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Governments Contracting Officer Representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the Contracting Officer.

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the contract; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

https://www.cpars.gov/ https://www.cpars.gov/lc.htm

The following Contracting Officer Representative (COR) will represent the Government for the purpose of this contract (To be provided upon contract award):

Name:

Email address:

Phone:

The contact information for the Contract Specialist:

Name: Yolanda Rankin Email Address: Yolanda.rankin@fda.hhs.gov Phone: (214) 253-4954

Occupational Safety and Health Terms and Conditions

Section I – General Occupational Safety and Health TERMS AND CONDITIONS:

1. The contractor is responsible for ensuring contractor personnel comply with applicable OSHA requirements, report unsafe conditions or activities to the Contracting Officer’s Representative (COR), and avoid actions and conditions that may result in an accident.

2. The contractor shall submit to the COR a site-specific safety and accident prevention plan and OSHA 300A reports from the past three calendar years.

3. The contractor shall report all workplace incidents, accidents, injuries, and near-misses that occur within the scope of the acquisition (whether OSHA-recordable or not) to the COR by email as soon as possible, but no more than 24-hours after discovery of the incident, illness or injury, or near-miss.

4. The contractor shall provide an investigation report at no cost to the Government for all workplace incidents, accidents, injuries, and near-misses that occur within the scope of the acquisition (whether OSHA-recordable or not) to the COR by email as soon as possible, but no more than 24-hours after the conclusion of the investigation of the incident, illness or injury, or near-miss.

5. The contractor shall report all activities or conditions that pose imminent danger or harm to persons, animals, or Government property immediately upon discovery to FDA Security or directly to local emergency services, as appropriate. In addition, the contractor shall report the incident to the COR immediately thereafter.

6. The contractor shall be responsible for any and all costs, expenses, and other obligations paid or incurred, due to the contractor’s noncompliance with federal, state, and/or local laws or ordinances.

7. As applicable, the contractor shall provide personal protective equipment (e.g., hard hats, safety glasses, work gloves) for anticipated hazards and ensure that contractor personnel wear the prescribed safety and health equipment within the work area, as prescribed by 29 CFR part 1910, Subpart I. The contractor shall provide instructions to personnel on the proper wear, maintenance, and limitations of the personal protective equipment prior to commencement of any work under the acquisition.

8. Prior to bringing any hazardous material to an FDA facility, the contractor shall provide the COR copies of any Safety Data Sheets (SDS) to obtain advance, written authorization.

8.1. Unless otherwise specified in the acquisition, the contractor is responsible for removing any hazardous material, or any material with an SDS, that the contractor brought with them for use at an FDA facility before or during performance of the acquisition.

Contractor Personnel Security Clearance Standards and Residency Requirements (October 2017)

1. BACKGROUND - The Office of the Assistant Secretary for Management and Budget, Department of Health and Human Services (DHHS), requires that Contractor employees (including subcontractors) who will be working in DHHS-owned or leased space and/or who will have access to DHHS equipment, and non-public privileged, proprietary, or trade secret information, must undergo a background investigation that results in a favorable determination.

Contractor employees who will work in DHHS-owned or leased space for less than thirty (30) days are considered visitors and are exempted from background investigation requirements; and therefore, will not be issued a Personal Identity Verification (PIV) Card. These contractor employees go through visitor screening each day and must be escorted at all time while in DHHS- owned or leased space.

2. GENERAL - The Contractor must submit the following items to the Contracting Officer’s Representative (COR), within five (5) business days of commencement of work under this contract:

A roster of contractor employee names, identifying Key Personnel and Tier designation(s);

Confirmation all individual employee security information has been submitted properly; and

"Contractor's Commitment to Protect Non-public Information Agreement" forms signed by each employee named in the roster.

Pursuant to HSPD-12, the Contractor must advise its prospective employees about the security and background requirements stated herein.

For any individual who does not obtain a favorable background investigation he/she must cease work on the contract immediately.

If a Contractor employee changes job responsibilities under this contract, the Contractor must notify the COR, and the Government will make a determination whether an additional security clearance is required.

In the event there are any proposed personnel changes in the Contractor’s staffing roster previously submitted to the COR, the Contractor must submit an updated roster to the COR, along with a brief explanation for the change. In turn, the COR will initiate the procedures stated herein to ensure any new contractor employees obtain a PIV card in a timely manner – prior to that individual commencing work under the contract.

Note: If the proposed personnel change is for a position designated Key Personnel under the contract, a complete justification – along with a resume or curriculum vitae – must be submitted to the Contracting Officer and COR for review and approval. If approved, the Contracting Officer will execute a Contract Modification prior to that individual commencing work under the contract.

3. BACKGROUND INVESTIGATIONS - With the exception of costs associated with fingerprinting Contractor employees outside of the FDA Personnel Security Office, the Government will conduct all required background investigations at no cost to the Contractor. The cost of fingerprinting Contractor employees at any location other than the FDA Personnel Security Office will be borne by the Contractor. Employees who hold or have previously held a Government security clearance must advise the FDA Personnel Security Staff of the details of such clearance.

Note: Background investigations will be conducted by the Office of Personnel Management

(OPM)

4. CONTRACT RISK DESIGNATION(S) - Contractor employees who will be in DHHS-owned or leased space for thirty (30) days or more must be able to obtain and shall obtain a PIV card pursuant to Homeland Security Presidential Directive-12 (HSPD-12) in order to access to DHHS-owned or leased property without an escort. (See Section 6 for details on the PIV Card process) However, in the event that work must commence before a security screening can be completed, contractor employees will be considered visitors, as described above, and allowed onto DHHS-owned or leased property, but must be escorted at all times.

All Contractor employees who undergo a background investigation are required to log onto the Office of Personnel Management’s (OPM’s) Electronic Questionnaire for Investigation Processing system (e-Qip) system. The FDA Personnel Security Specialist will provide access to the e-Qip as well as guidance as to which forms will be required. The forms required vary with the position risk designations for the contract.

All standard forms submitted to the FDA will be forwarded to the Office of Personnel Management (OPM) to initiate background investigations. The assigned FDA Personnel Security Specialist will resolve with the contractor employee any issues arising out of inaccurate or incomplete forms.

The Risk Designation(s) for this contract is/are Tier(s):

[Contracting Officer (in consultation with Program Personnel) designates risk as Tier(s) 1, 2, and/or 4].

There are three (3) potential position risk designations, which are:

Non-Sensitive Low Risk (Tier 1) - Positions which involve the lowest degree of adverse impact on the efficiency of the Agency. The forms set forth by the FDA Personnel Security Specialist are required for Non-Sensitive Low Risk Positions.

Sensitive Moderate Risk (Tier 2) or Sensitive High Risk (Tier 4) - Public Trust Positions - Positions in which the incumbent's actions or inaction could diminish public confidence in the integrity, efficiency, or effectiveness of assigned Government activities, whether or not actual damage occurs.

In order to access the e-QIP system, Contractor employees must provide the appropriate FDA Personnel Security Specialist with the following information: (a) full name; (b) position title; (c) social security number; (d) date of birth; (e) place of birth; (f) email address; and (g) phone number.

This information will be provided on the e-Qip form that will be electronically sent to the employee.

The FDA Personnel Security Specialist will use this information to enter each Contractor employee into the e-QIP system. Once this is done, each Contractor employee will receive an email that contains a web link to access the e-QIP system, as well as instructions and additional forms needed to initiate the background investigation.

A Contractor’s failure to comply with the e-QIP processing guidelines will result in that Contractor’s employees being denied access to FDA property until all security processing has been completed.

Furthermore, any such noncompliance may detrimentally impact Contractor performance, Contractor performance evaluations, rights and remedies available at law and equity retained by the Government.

5. PERSONAL IDENTITY VERIFICATION (PIV) CARDS - All PIV Cards (and any other type of Government-issued Access Card) shall remain the property of the Federal Government. At any time, if a Contractor employee is terminated or otherwise ceases work under the contract, or no longer requires a PIV Card for contract performance purposes, the Contractor must collect the individual’s PIV card and immediately notify FDA Personnel Security Staff in writing, with copies to the respective COR and Contracting Officer. The Contractor must immediately return the PIV Card(s) to the COR.

Because PIV Cards, like other Government-issued Access Cards are Government property, Contractors and Contractor Employees are hereby placed on notice that any abuse, destruction, defacement, unauthorized transfer or withholding (i.e., failure to return to the Government) may be punishable to the greatest extent at law.

Unauthorized possession of a PIV Card, or any other type of Government-issued Access Card, and/or willfully allowing any other person to have or to use your Access Card, is prohibited and can be criminally prosecuted under 18 U.S.C. §§ 499 and 70I, which prohibit photographing or otherwise reproducing or possessing HHS identification cards in an unauthorized manner, under penalty of fine, imprisonment, or both. Wrongdoers may also be held financially responsible for any/all civil and equitable remedies – to include, but not limited to, damages for any pecuniary loss suffered by the Government as a result of any of the above-listed actions or failure to act.

6. PIV CARD PROCESS - The COR will sponsor Contractor employees on the Form HHS 745 and HHS Smart Card Management System (SCMS) for the purpose of obtaining an FDA PIV Card.

In order to obtain a PIV card, a Contractor employee must receive a favorable FBI fingerprint return and complete required security forms. The FDA Personnel Security Specialist will provide the Contractor employee(s) direction for scheduling fingerprinting appointments at the FDA location or other approved location.

During a fingerprint appointment, each contractor employee must present two (2) forms of identification in order to receive his or her PIV Card. One form of identification must be a government-issued photo identification document. Acceptable forms of identification are listed in

Appendix A, provided below. An individual who receives an unfavorable report may appeal that finding by submitting a written request to the FDA Personnel Security Specialist.

Required background investigations may include, but are not limited to:

Review of prior Government/military personnel records;

Review of FBI records and fingerprint files;

Searches of credit bureaus;

Personal interviews; and

Written inquiries covering the subject's background.

7. RESIDENCY REQUIREMENTS FOR FOREIGN NATIONALS - Under the requirements for Homeland Security Presidential Directive-12 (HSPD-12), OPM can complete a background investigation only for persons who have resided in the U.S. for a total of at least three (3) of the past five (5). The residency requirements apply only to foreign nationals. If any prospective foreign national contractor/subcontractor employee does not meet the residency requirements, he/she cannot qualify for a PIV Card under HSPD-12.

8. NON-PUBLIC DATA PROTECTION - The Contractor must protect the privacy of all information reported by or about Contractor employees and protect against unauthorized disclosure.

*Upon a favorable fingerprint return, the Contractor will be notified to return to the Badging and Credentialing Office for their building pass.

*Food and Drug Administration Badging and Credentialing Office

8:00 a.m. – 11:00 a.m. and 1:00 p.m. – 3:00 p.m., Eastern Time 10903 New Hampshire Avenue

Building 32, Room 1205 Silver Spring, MD 20993

No appointment necessary Telephone: (301) 796-4000

Appendix A

The following additional provisions and/or clauses apply and incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at https://www.acquisition.gov/far/ The following FAR and HHSAR clauses, incorporated by reference, apply to this acquisition.

FAR Clause 52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (May 2011)

FAR 52.204-13 System For Award Management Maintenance (Oct 2018)

FAR 52.204-18 Commercial and Government Entity Code Maintenance (Aug 2020)

FAR 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) https://www.acquisition.gov/far/

FAR 52.217-9 Option To Extend the Term of the Contract (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor any time before the contract expires; provided that the Government gives the Contractor a preliminary written notice of its intent to extend anytime before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 4 years excluding the period set forth for delivery and warranty.

HHSAR Clauses:

HHSAR Clause 352.203-70 Anti-Lobbying (Dec 2015) HHSAR Clause 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) HHSAR Clause 352.223-70 Safety and Health (Dec 2015)

HHSAR 352.232-71 Electronic Submission of Payment Requests (FEB 2022)

(a) Definitions. As used in this clause-

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(END OF CLAUSE)

HHSAR 352.239-74 Electronic and Information Technology Accessibility (December 18, 2015)

Paragraph (c). The Section 508 standards applicable to this contract are:

• Must meet WCAG 2.0 A and AA

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements)

• E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)

• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements)

• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements)

• Electronic content must be accessible to HHS acceptance criteria.

• Accessibility checklists for various formats are available at the HHS site. Materials that are final items must be compliant with Section 508 at time of delivery, except upon approval of the Contracting Officer or Representative.

• E207 Software (Appendix A, Application and Scoping Requirements)

• Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements)

Payments

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S.

Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

https://www.hhs.gov/web/section-508/accessibility-checklists/index.html http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and

(2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

• Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

• Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

• Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

• Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

• Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

• Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

• Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827- ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

Payments will not be made more frequently than monthly in arrears. Advance payments will not be made.

QUESTIONS CONCERNING TERMS OF THIS ORDER (Other than invoice-related) SHOULD BE DIRECTED TO: Yolanda Rankin (214) 253-4954 or yolanda.rankin@fda.hhs.gov

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to:

(1) Direct or negotiate any changes in the statement of work;

(2) Modify or extend the period of performance;

(3) Change the delivery schedule

(4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or

(5) Otherwise change any terms and conditions of this contract.

The Contract Officer for this order is:

XXXXX, Contracting Officer

3900 NCTR Road

HFT-320

Jefferson, AR 72079

Phone: (870) 543-XXXX

Email: xxxxxx@fda.gov

The TPOC is responsible for:

Monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;

(2) Interpreting the statement of work and any other technical performance requirements;

(3) Performing technical evaluation as required;

mailto:yolanda.rankin@fda.hhs.gov mailto:xxxxxx@fda.gov

(4) Performing technical inspections and acceptances required by this contract and;

(5) Assisting in the resolution of technical problems encountered during performance.

The TPOC for this order is:

To be identified at time of award.

52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services (Dec 2023)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities (DEC 2023) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (MAR 2023) ( 31 U.S.C. 3903 and 10 U.S.C. 3801).

(6) 52.233-3, Protest After Award (AUG 1996) ( 31 U.S.C. 3553).

(7) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108-78 ( 19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

[Contracting Officer check as appropriate.]

X (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUN 2020), with Alternate I (NOV 2021) ( 41 U.S.C. 4704 and 10 U.S.C. 4655).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (NOV 2021) ( 41 U.S.C. 3509)).

https://www.acquisition.gov/far/part-52#FAR_52_203_19 https://www.acquisition.gov/far/part-52#FAR_52_204_23 https://www.acquisition.gov/far/part-52#FAR_52_204_25 https://www.acquisition.gov/far/part-52#FAR_52_209_10 https://www.acquisition.gov/far/part-52#FAR_52_232_40 https://www.govinfo.gov/link/uscode/31/3903 https://www.govinfo.gov/link/uscode/31/3903 https://www.govinfo.gov/link/uscode/10/3801 https://www.acquisition.gov/far/part-52#FAR_52_233_3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_233_4 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_203_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.govinfo.gov/link/uscode/10/4655 https://www.acquisition.gov/far/part-52#FAR_52_203_13 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

X (4) 52.203-17, Contractor Employee Whistleblower Rights (NOV 2023) ( 41 U.S.C. 4712); this clause does not apply to contracts of DoD, NASA, the Coast Guard, or applicable elements of the intelligence community—see FAR 3.900(a).

X (5) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).

__ (6) [Reserved].

X (7) 52.204-14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (8) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L. 111-117, section 743 of Div. C).

X (9) 52.204-27, Prohibition on a ByteDance Covered Application (JUN 2023) (Section 102 of Division R of Pub. L. 117-328).

(10) 52.204–28, Federal Acquisition Supply Chain Security Act Orders—Federal Supply Schedules, Governmentwide Acquisition Contracts, and Multi-Agency Contracts. (DEC 2023) ( Pub. L. 115– 390, title II).

__ (11) (i) 52.204–30, Federal Acquisition Supply Chain Security Act Orders—Prohibition. (DEC 2023) ( Pub. L. 115–390, title II).

__ (ii) Alternate I (DEC 2023) of 52.204–30.

X (12) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (NOV 2021) ( 31 U.S.C. 6101 note).

X (13) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OCT 2018) ( 41 U.S.C. 2313).

__ (14) [Reserved].

__ (15) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (OCT 2022) ( 15 U.S.C. 657a).

X (16) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) ( 15 U.S.C. 657a).

__ (17) [Reserved] https://www.acquisition.gov/far/part-52#FAR_52_203_15 https://www.acquisition.gov/far/part-52#FAR_52_203_17 https://www.govinfo.gov/link/uscode/41/4712 https://www.acquisition.gov/far/part-3#FAR_3_900 https://www.acquisition.gov/far/part-52#FAR_52_204_10 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_204_14 https://www.acquisition.gov/far/part-52#FAR_52_204_15 https://www.acquisition.gov/far/part-52#FAR_52_204_27 https://www.govinfo.gov/link/plaw/115/public/390 https://www.govinfo.gov/link/plaw/115/public/390 https://www.govinfo.gov/link/plaw/115/public/390 https://www.acquisition.gov/far/part-52#FAR_52_209_6 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_209_9 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section2313&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_219_3 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section637a&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_219_4

__ (18) (i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) ( 15 U.S.C. 644).

__ (ii) Alternate I (MAR 2020) of 52.219-6.

__ (19) (i) 52.219-7, Notice of Partial Small Business Set-Aside (NOV 2020) ( 15 U.S.C. 644).

__ (ii) Alternate I (MAR 2020) of 52.219-7.

X (20) 52.219-8, Utilization of Small Business Concerns (SEP 2023) ( 15 U.S.C. 637(d)(2) and (3)).

__ (21) (i) 52.219-9, Small Business Subcontracting Plan (SEP 2023) ( 15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (NOV 2016) of 52.219-9.

__ (iii) Alternate II (NOV 2016) of 52.219-9.

__ (iv) Alternate III (JUN 2020) of 52.219-9.

__ (v) Alternate IV (SEP 2023) of 52.219-9.

__ (22) (i) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) ( 15 U.S.C. 644(r)).

__ (ii) Alternate I (MAR 2020) of 52.219-13.

__ (23) 52.219-14, Limitations on Subcontracting (OCT 2022) ( 15 U.S.C. 637s).

__ (24) 52.219-16, Liquidated Damages—Subcontracting Plan (SEP 2021) ( 15 U.S.C. 637(d)(4)(F)(i)).

__ (25) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (OCT 2022) ( 15 U.S.C. 657f).

X (26) (i) 52.219-28, Post Award Small Business Program Rerepresentation (SEP 2023)( 15 U.S.C. 632(a)(2)).

__ (ii) Alternate I (MAR 2020) of 52.219-28.

__ (27) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (OCT 2022) ( 15 U.S.C. 637(m)).

__ (28) 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (OCT 2022) ( 15 U.S.C. 637(m)).

__ (29) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) ( 15 U.S.C. 644(r)).

https://www.acquisition.gov/far/part-52#FAR_52_219_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_6 https://www.acquisition.gov/far/part-52#FAR_52_219_7 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_7 https://www.acquisition.gov/far/part-52#FAR_52_219_8 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_9 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://www.acquisition.gov/far/part-52#FAR_52_219_13 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_13 https://www.acquisition.gov/far/part-52#FAR_52_219_14 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_16 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_27 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_28 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_28 https://www.acquisition.gov/far/part-52#FAR_52_219_29 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_30 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_32 https://www.govinfo.gov/content/pkg/USCODE-2018-title15/html/USCODE-2018-title15-chap14A-sec644.htm

__ (30) 52.219-33, Nonmanufacturer Rule (SEP 2021) ( 15U.S.C. 637(a)(17)).

X (31) 52.222-3, Convict Labor (JUN 2003) (E.O.11755).

X (32) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (NOV 2023) .

X (33) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

X (34) (i) 52.222-26, Equal Opportunity (SEP 2016) (E.O.11246).

__ (ii) Alternate I (FEB 1999) of 52.222-26.

X (35) (i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) ( 38 U.S.C. 4212).

__ (ii) Alternate I (JUL 2014) of 52.222-35.

X (36) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) ( 29 U.S.C. 793).

__ (ii) Alternate I (JUL 2014) of 52.222-36.

X (37) 52.222-37, Employment Reports on Veterans (JUN 2020) ( 38 U.S.C. 4212).

X (38) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496).

X (39) (i) 52.222-50, Combating Trafficking in Persons (NOV 2021) ( 22 U.S.C. chapter 78 and E.O.

13627).

__ (ii) Alternate I (MAR 2015) of 52.222-50 ( 22 U.S.C. chapter 78 and E.O. 13627).

X (40) 52.222-54, Employment Eligibility Verification (MAY 2022) (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

__ (41) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for…